Search Results

The Synthes Synsonic Ulna Nail System consists of intramedullary nails with end caps and locking tacks designed to treat fractures of the ulna. The system makes use of an ultrasonic generator to deliver energy through a handpiece to securely fasten the locking tacks to the surface of the nail. The handpiece features a force sensor mechanism that provides feedback to the surgeon on the amount of load applied to the locking tack. An audible tone indicates when the correct pressure range is achieved to allow fixation of the tack to the nail. The ulnar nail and locking tack implants are composed of PEEK-Optima® polymer material and implant grade stainless steel. Locking of the tack to the nail creates a fixed angle construct that provides rotational alignment, torsional stability and axial control of the fractured ulna.

AI/ML Overview

The provided text describes the 510(k) summary for the Synthes Synsonic Ulna Nail System. This document focuses on the mechanical and electrical safety of the device, rather than its performance in an AI/diagnostic context. Therefore, the questions related to AI-specific elements like sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies are not applicable.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines the types of tests conducted to support the substantial equivalence of the Synthes Synsonic Ulna Nail System to predicate devices and to ensure its safe use. Specific acceptance criteria are mentioned for some tests.

Test Type	Acceptance Criteria	Reported Device Performance
Bench Testing for Substantial Equivalence
Static Cantilever Bend Testing	Implicit: Performance comparable to predicate devices.	The results of the bench testing indicate that the performance of the proposed Synsonic Ulna Nail System supports its substantial equivalence to the predicate devices.
Cyclic Torsion Testing	Implicit: Performance comparable to predicate devices.	The results of the bench testing indicate that the performance of the proposed Synsonic Ulna Nail System supports its substantial equivalence to the predicate devices.
Tack Removal Testing	Implicit: Performance comparable to predicate devices.	The results of the bench testing indicate that the performance of the proposed Synsonic Ulna Nail System supports its substantial equivalence to the predicate devices.
Nail Removal Testing	Implicit: Performance comparable to predicate devices.	The results of the bench testing indicate that the performance of the proposed Synsonic Ulna Nail System supports its substantial equivalence to the predicate devices.
Design Verification Testing (Risk Analysis)
Thermal Profile Testing	Compared to criteria for thermal bone injury documented in clinical literature.	The results of the safety tests conducted on the subject system met the established criteria and conform to the requirements of the relevant standards.
Electrical Safety	In accordance with IEC 60601-1.	The results of the safety tests conducted on the subject system met the established criteria and conform to the requirements of the relevant standards.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in terms of number of devices or units tested for each benchmark test. The document mentions "the subject device construct" for bench testing and "all of the components of proposed system" for electrical safety.
Data Provenance: The tests were "conducted on the subject device construct" and "on the proposed Synsonic Ulna Nail System," implying that the testing was performed directly on the manufactured device components. The location of the testing is not specified, but the applicant (Synthes) is based in West Chester, PA, USA. This is a prospective experimental study (lab testing) rather than a retrospective analysis of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a medical implant system and its evaluation focuses on mechanical and electrical safety and performance, not on diagnostic accuracy requiring expert interpretation of data or images. The "ground truth" for the thermal profile testing was "criteria for thermal bone injury documented in clinical literature," which represents established medical knowledge rather than expert consensus on a specific test set.

4. Adjudication method for the test set:

Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication. The tests involve quantifiable measurements against established engineering and safety standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not involve an algorithm for standalone performance evaluation in the context of AI.

7. The type of ground truth used:

The ground truth for the mechanical bench testing appears to be the performance characteristics of the predicate devices, against which the new device's performance was compared to establish "substantial equivalence."
For thermal profile testing, the ground truth was "criteria for thermal bone injury documented in clinical literature."
For electrical safety, the ground truth was the requirements specified in "IEC 60601-1" standard.

8. The sample size for the training set:

Not applicable. This device does not utilize machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

Ask a Question

Ask a specific question about this device

Page 1 of 1